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    Clinical Trial Results:
    A PHASE IV, OPEN LABEL, PILOT STUDY OF THE TREATMENT OF CHILDREN WITH MODERATE TO SEVERE ATOPIC DERMATITIS (AD) USING LOCOBASE REPAIR® AS AN ADJUNCTIVE TO STANDARD TREATMENT

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2006-006462-42
    Trial protocol
    		 GB  
    Global end of trial date
    16 Sep 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 May 2016
    First version publication date
    02 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    REP-EC-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00673725
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Acronym: REPAIR
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V.
    Sponsor organisation address
    P.O. Box 108, Leiderdorp, Netherlands, 2350 AC
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V., Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V., Astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Sep 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Sep 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe atopic dermatitis (AD)
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    2
    Children (2-11 years)
    38
    Adolescents (12-17 years)
    9
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects must have continuously used a topical corticosteroid/Topical Calcineurin Inhibitor (TCI) as active treatment for AD, at least 4 weeks prior to screening. Subjects should have met following wash-out criteria prior to screening: Systemic corticosteroids - 2 weeks, Other investigational drugs - 2 weeks, Light Treatments (UVA, UVB) - 4 weeks.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable, this was an open label study.

    Arms
    Arm title
    		 Locobase REPAIR® Twice daily
    Arm description
    		 Locobase REPAIR® cream to be applied twice daily to all areas with active lesions or dry skin either present at day 1 or that emerge during the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Locobase
    Investigational medicinal product code
    Other name
    REPAIR®
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Locobase REPAIR® is a water-in-oil (W/O) cream with a relatively high percentage of Vaseline and some soft paraffin and carnauba wax. To this solid paraffin has been added in the form of nanoparticles (solid particles with a diameter <1000 nm). The skin lipid fraction of the formulation consists of cholesterol, oleic acid, palmitic acid and ceramide-III in relatively high concentrations. There is no active ingredient in Locobase REPAIR®. Locobase REPAIR® cream was to be applied topically twice daily to all areas with active lesions or dry skin either present at day 1 or that emerged during the study.

    Number of subjects in period 1
    		Locobase REPAIR® Twice daily
    Started
    49
    Completed
    34
    Not completed
    15
         Withdrawal of consent
    3
         Lost to follow-up
    6
         Adverse event (AE)
    4
         Other (no adult to accompany patient)
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Locobase REPAIR® Twice daily
    Reporting group description
    		 Locobase REPAIR® cream to be applied twice daily to all areas with active lesions or dry skin either present at day 1 or that emerge during the study.

    Reporting group values
    		 Locobase REPAIR® Twice daily Total
    Number of subjects
    		 49 49
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age values are based on the Safety Analysis Population (SAF). The SAF consisted of all enrolled patients who used Locobase REPAIR®.
    Units: years
        arithmetic mean (standard deviation)
    		 7 ( 4.1 ) -
    Gender categorical
    Gender values are based on the SAF.
    Units: Subjects
        Female
    		 20 20
        Male
    		 29 29

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Locobase REPAIR® Twice daily
    Reporting group description
    		 Locobase REPAIR® cream to be applied twice daily to all areas with active lesions or dry skin either present at day 1 or that emerge during the study.

    Subject analysis set title
    AD Cleared
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The study analysis population for this endpoint consisted of the Full Analysis Set (FAS). The FAS consisted of all enrolled patients who used Locobase REPAIR® and had the baseline and a post-baseline Eczema Area and Severity Index (EASI) completed (i.e., the Physician’s Assessments of Individual Signs (PAIS) and Affected Area and the Patient’s Assessment of Itch (PAI) were completed). Last observation carried forward (LOCF) analysis.

    Subject analysis set title
    Excellent Improvement in AD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS, LOCF analysis.

    Subject analysis set title
    Marked Improvement in AD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS, LOCF analysis.

    Subject analysis set title
    Moderate Improvement in AD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS, LOCF analysis.

    Subject analysis set title
    Slight Improvement in AD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS, LOCF analysis.

    Subject analysis set title
    AD Improvement Not Appreciable
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS, LOCF analysis.

    Subject analysis set title
    AD Worsened
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS, LOCF analysis.

    Subject analysis set title
    Head and Neck Erythema Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Erythema Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Erythema Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Erythema Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Edema/induration/papulation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Edema/induration/papulation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Edema/induration/papulation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Edema/induration/papulation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Excoriation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Excoriation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Excoriation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Excoriation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Oozing/weeping/crusting Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Oozing/weeping/crusting Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Oozing/weeping/crusting Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Oozing/weeping/crusting Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Scaling Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Scaling Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Scaling Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Scaling Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Lichenification Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Lichenification Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Lichenification Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Head and Neck Lichenification Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Erythema Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Erythema Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Erythema Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Erythema Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Edema/induration/papulation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Edema/induration/papulation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Edema/induration/papulation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Edema/induration/papulation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Excoriation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Excoriation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Excoriation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Excoriation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Oozing/weeping/crusting Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Oozing/weeping/crusting Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Oozing/weeping/crusting Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Oozing/weeping/crusting Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Scaling Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Scaling Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Scaling Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Scaling Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Lichenification Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Lichenification Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Lichenification Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Upper Limbs Lichenification Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Erythema Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Erythema Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Erythema Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Erythema Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Edema/induration/papulation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Edema/induration/papulation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Edema/induration/papulation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Edema/induration/papulation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Excoriation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Excoriation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Excoriation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Excoriation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Oozing/weeping/crusting Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Oozing/weeping/crusting Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Oozing/weeping/crusting Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Oozing/weeping/crusting Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Scaling Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Scaling Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Scaling Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Scaling Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Lichenification Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Lichenification Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Lichenification Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Trunk Lichenification Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Erythema Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Erythema Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Erythema Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Erythema Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Edema/induration/papulation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Edema/induration/papulation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Edema/induration/papulation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Edema/induration/papulation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Excoriation Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Excoriation Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Excoriation Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Excoriation Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Oozing/weeping/crusting Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Oozing/weeping/crusting Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Oozing/weeping/crusting Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Oozing/weeping/crusting Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Scaling Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Scaling Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Scaling Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Scaling Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Lichenification Absent
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Lichenification Mild
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Lichenification Moderate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Lower Limbs Lichenification Severe
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Physician's assessment of individual signs.

    Subject analysis set title
    Locobase REPAIR® Twice daily Week 3 LOCF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population

    Subject analysis set title
    Summary Statistics at Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    Summary Statistics at Week 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    Summary Statistics Week 3 LOCF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    AD Much Improved
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    AD Improved
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    AD Slightly Improved
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    AD Same
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    AD Slightly Worse
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    AD Worse
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    AD Much Worse
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    Patients with at least one visit to a GP
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population. General Practitioner (GP).

    Subject analysis set title
    Patients with at least one outpatient visit to a hospital
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS population.

    Subject analysis set title
    Application site
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAF) population. The SAF consisted of all enrolled patients who used Locobase REPAIR®.

    Subject analysis set title
    Non-application site
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SAF population.

    Subject analysis set title
    Overall Participants with Treatment-Emergent Adverse Events
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SAF population.

    Primary: Change in the modified Eczema Area and Severity Index (mEASI) from baseline to Week 3

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    End point title
    		 Change in the modified Eczema Area and Severity Index (mEASI) from baseline to Week 3
    End point description
    The study analysis population for this endpoint consisted of the Full Analysis Set (FAS). The FAS consisted of all enrolled patients who used Locobase REPAIR® and had the baseline and a post-baseline EASI completed (i.e., the Physician’s Assessments of Individual Signs (PAIS) and Affected Area and the Patient’s Assessment of Itch (PAI) were completed). The mEASI is not an assessment but a score based on the PAIS and affected area and the PAI. The mEASI was calculated by the sponsor at the time of analysis. The modified EASI combined the EASI and the Itch Score (IS). The Investigator completed the Affected Area Scores (AAS) for each body region and the PAIS for signs of AD. mEASI (< 7 years old at baseline) = EASI + IS X (AAS Head/Neck (H/N) x 0.2 + AAS Upper Limbs (UL) x 0.2 + AAS Trunk x 0.3 + AAS Lower Limbs (LL) x 0.3) mEASI (≥ 7 years old at baseline) = EASI + IS X (AAS H/N x 0.1 + AAS UL x 0.2 + AAS Trunk x 0.3 + AAS LL x 0.4) Highest possible score was: 72 + 18 = 90.
    End point type
    Primary
    End point timeframe
    Baseline to Week 3.
    End point values
    		 Locobase REPAIR® Twice daily Locobase REPAIR® Twice daily Week 3 LOCF Summary Statistics at Baseline Summary Statistics at Week 3 Summary Statistics Week 3 LOCF
    Number of subjects analysed
    30 [1]
    41 [2]
    43 [3]
    30 [4]
    41 [5]
    Units: mEASI (see description)
        arithmetic mean (standard deviation)
    -7.77 ( 11.55 )
    -6.73 ( 10.72 )
    17.25 ( 12.78 )
    9.76 ( 8.63 )
    10.99 ( 10.06 )
    Notes
    [1] - Change in mEASI from baseline to Week 3.
    [2] - Change in mEASI from baseline to Week 3 LOCF. Two patients had a missing mEASI at Week 3.
    [3] - Summary Statistics at Baseline.
    [4] - Summary Statistics at Week 3.
    [5] - Summary Statistics Week 3 LOCF. Two patients had a missing mEASI at Week 3.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The hypothesis for the comparison is given as follows: H0: There is no change in the mEASI at week 3 compared to baseline H1: There is a change in the mEASI at week 3 compared to baseline There were actually 30 subjects in this analysis, since the comparison includes the subjects at baseline and week 3.
    Comparison groups
    Summary Statistics at Baseline v Summary Statistics at Week 3
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.0009 [7]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [6] - The primary variable was tested by use of a 2-sided paired t-test at a significance level of 5% on patients of the FAS who had a mEASI at week 3.
    [7] - Two-sided paired t-test (α=0.05) t-value= -3.69
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    The hypothesis for the comparison is given as follows: H0: There is no change in the mEASI at week 3 compared to baseline H1: There is a change in the mEASI at week 3 compared to baseline There were actually 41 subjects in this analysis, since the comparison includes the subjects at baseline and week 3 LOCF (Two patients had a missing mEASI at Week 3).
    Comparison groups
    Summary Statistics at Baseline v Summary Statistics Week 3 LOCF
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.0003 [9]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [8] - The primary variable was tested by use of a 2-sided paired t-test at a significance level of 5% on patients of the FAS who had a mEASI at week 3 (including data imputed using a LOCF approach). Two patients had a missing mEASI at Week 3.
    [9] - Two-sided paired t-test (α=0.05) t-value=-4.02

    Secondary: Change in the mEASI from baseline to Day 10 and Week 6

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    End point title
    		 Change in the mEASI from baseline to Day 10 and Week 6
    End point description
    The study analysis population for this endpoint consisted of the FAS.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 10 and Week 6.
    End point values
    		 Locobase REPAIR® Twice daily
    Number of subjects analysed
    43
    Units: mEASI
    arithmetic mean (standard deviation)
        Day 10 [n=36)
    -7.5 ( 9.69 )
        Week 6 [n=28]
    -7.5 ( 10.88 )
        Week 6 LOCF [n=42]
    -7.31 ( 10.87 )
    No statistical analyses for this end point

    Secondary: Change in the Eczema Area and Severity Index (EASI) from baseline to Day 10, Week 3 and Week 6

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    End point title
    		 Change in the Eczema Area and Severity Index (EASI) from baseline to Day 10, Week 3 and Week 6
    End point description
    The study analysis population for this endpoint consisted of the FAS. The EASI is not an assessment but a score based on the Physician’s Assessment of Individual Signs (for four signs of atopic dermatitis: Erythema, Edema/Induration/Papulation, Excoriation, Lichenification) and the Affected Area Assessment (for each of four defined body regions: Head/Neck, Upper Limbs, Trunk, Lower Limbs). EASI CALCULATION TOTAL EASI (<7 years old at baseline) = Head/Neck (Subtotal) x 0.2+ Upper Limbs (Subtotal) x 0.2 + Trunk (Subtotal) x 0.3 + Lower Limbs (Subtotal) x 0.3 TOTAL EASI (≥7 years old at baseline) = Head/Neck (Subtotal) x 0.1+ Upper Limbs (Subtotal) x 0.2 + Trunk (Subtotal) x 0.3 + Lower Limbs (Subtotal) x 0.4
    End point type
    Secondary
    End point timeframe
    Baseline to Day 10, Week 3 and Week 6.
    End point values
    		 Locobase REPAIR® Twice daily
    Number of subjects analysed
    43
    Units: EASI (see description)
    arithmetic mean (standard deviation)
        Day 10 [n=37]
    -4.79 ( 6.65 )
        Week 3 [n=30]
    -4.88 ( 7.72 )
        Week 3 LOCF [n=42]
    -4.13 ( 7.13 )
        Week 6 [n=30]
    -4.09 ( 7.29 )
        Week 6 LOCF [n=43]
    -4.46 ( 7.39 )
    No statistical analyses for this end point

    Secondary: Change in Patient’s Assessment of Itch from baseline to Day 10, Week 3 and Week 6

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    End point title
    		 Change in Patient’s Assessment of Itch from baseline to Day 10, Week 3 and Week 6
    End point description
    The study analysis population for this endpoint consisted of the FAS. Itch was assessed by the subject on a 10 cm visual analogue scale (VAS). The distance between the upper end of the scale ("No Itch") and the subject's mark on the scale was measured by the sponsor. The calculation was based on a modified EASI, the distance was categorized to values 0, 1, 2 and 3 as follows: Itch score measured distance 0 0 - <2.5 cm 1 2.5 - <5 cm 2 5 - <7.5 cm 3 7.5 - 10 cm Summary statistics for the observed value at each visit, including LOCF, and changes from baseline for the Itch Score (the classified itch assessment in 0, 1, 2 3) were not analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 10, Week 3 and Week 6.
    End point values
    		 Locobase REPAIR® Twice daily
    Number of subjects analysed
    43
    Units: Itch VAS (cm)
    arithmetic mean (standard deviation)
        Day 10 [n=36]
    -2.12 ( 2.91 )
        Week 3 [n=30]
    -2.42 ( 3.17 )
        Week 3 LOCF [n=41]
    -2.1 ( 3.26 )
        Week 6 [n=28]
    -2.76 ( 3.28 )
        Week 6 LOCF [n=42]
    -2.34 ( 3.25 )
    No statistical analyses for this end point

    Secondary: Change in Physician's Global Evaluation of Clinical Response from baseline to Day 10, Week 3 and Week 6

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    End point title
    		 Change in Physician's Global Evaluation of Clinical Response from baseline to Day 10, Week 3 and Week 6
    End point description
    The study analysis population for this endpoint consisted of the FAS. The Physician’s Global Evaluation of Clinical Response rates the change for all areas affected on the whole body on day 1 compared to defined visits. The physician completed the following at defined visits during the course of the study: “Consider the patient’s atopic dermatitis as a whole, how it looks, how it feels, how others react to it, etc. Since the patient started his/her first treatment with the study substance, do you think the condition is/shows”: % Improvement (Except for residual discolouration) Cleared: 100 Excellent Improvement: 90-99 Marked Improvement: 75-89 Moderate Improvement: 50-74 Slight Improvement: 30-49 No Appreciable Improvement: 0-29 Worse: < 0
    End point type
    Secondary
    End point timeframe
    Baseline to Day 10, Week 3 and Week 6.
    End point values
    		 AD Cleared Excellent Improvement in AD Marked Improvement in AD Moderate Improvement in AD Slight Improvement in AD AD Improvement Not Appreciable AD Worsened
    Number of subjects analysed
    43
    43
    43
    43
    43
    43
    43
    Units: percentage of participants
    number (not applicable)
        Day 10 [n=37]
    2.7
    5.4
    29.7
    16.2
    24.3
    18.9
    2.7
        Week 3 [n=30]
    0
    10
    23.3
    23.3
    20
    10
    13.3
        Week 3 LOCF [n=42]
    2.4
    7.1
    21.4
    21.4
    19
    16.7
    11.9
        Week 6 [n=30]
    0
    13.3
    30
    33.3
    3.3
    10
    10
        Week 6 LOCF [n=43]
    0
    11.6
    25.6
    27.9
    11.6
    14
    9.3
    No statistical analyses for this end point

    Secondary: Change in Total Affected Body Surface Area from baseline to Day 10, Week 3 and Week 6

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    End point title
    		 Change in Total Affected Body Surface Area from baseline to Day 10, Week 3 and Week 6
    End point description
    The study analysis population for this endpoint consisted of the FAS. Grading Scale: (Physician`s Assessment of Individual Signs) 0 = None 1 = Mild 2 = Moderate 3 = Severe Sum of Erythema/Induration/Papulation,Excoriation, Lichenification on defined body regions Head/Neck, Upper Limbs, Trunk, Lower Limbs Affected Area Score: Score 0 1 2 3 4 5 6 Affected Area (%) 0 1-9 10-29 30-49 50-69 70-89 90-100 4 Subtotal = Sum2 x Affected Area Score (0-6)^3
    End point type
    Secondary
    End point timeframe
    Baseline to Day 10, Week 3 and Week 6.
    End point values
    		 Locobase REPAIR® Twice daily
    Number of subjects analysed
    43
    Units: percentage of participants
    arithmetic mean (standard deviation)
        Day 10 [n=37]
    -5.49 ( 11.95 )
        Week 3 [n=30]
    -4.86 ( 14.87 )
        Week 3 LOCF [n=42]
    -4.13 ( 13.74 )
        Week 6 [n=30]
    -7.56 ( 16.6 )
        Week 6 LOCF [n=43]
    -6.88 ( 14.62 )
    No statistical analyses for this end point

    Secondary: Physician’s Assessment of Individual Signs

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    End point title
    		 Physician’s Assessment of Individual Signs
    End point description
    The study analysis population for this endpoint consisted of the FAS. Grading Scale: (Physician`s Assessment of Individual Signs) 0 = None 1 = Mild 2 = Moderate 3 = Severe Sum of Erythema/Induration/Papulation,Excoriation, Lichenification on defined body regions Head/Neck, Upper Limbs, Trunk, Lower Limbs Affected Area Score: Score 0 1 2 3 4 5 6 Affected Area (%) 0 1-9 10-29 30-49 50-69 70-89 90-100 4 Subtotal = Sum2 x Affected Area Score (0-6)^3
    End point type
    Secondary
    End point timeframe
    Baseline, Day 10, Week 3 and Week 6.
    End point values
    		 Head and Neck Erythema Absent Head and Neck Erythema Mild Head and Neck Erythema Moderate Head and Neck Erythema Severe Head and Neck Edema/induration/papulation Absent Head and Neck Edema/induration/papulation Mild Head and Neck Edema/induration/papulation Moderate Head and Neck Edema/induration/papulation Severe Head and Neck Excoriation Absent Head and Neck Excoriation Mild Head and Neck Excoriation Moderate Head and Neck Excoriation Severe Head and Neck Oozing/weeping/crusting Absent Head and Neck Oozing/weeping/crusting Mild Head and Neck Oozing/weeping/crusting Moderate Head and Neck Oozing/weeping/crusting Severe Head and Neck Scaling Absent Head and Neck Scaling Mild Head and Neck Scaling Moderate Head and Neck Scaling Severe Head and Neck Lichenification Absent Head and Neck Lichenification Mild Head and Neck Lichenification Moderate Head and Neck Lichenification Severe Upper Limbs Erythema Absent Upper Limbs Erythema Mild Upper Limbs Erythema Moderate Upper Limbs Erythema Severe Upper Limbs Edema/induration/papulation Absent Upper Limbs Edema/induration/papulation Mild Upper Limbs Edema/induration/papulation Moderate Upper Limbs Edema/induration/papulation Severe Upper Limbs Excoriation Absent Upper Limbs Excoriation Mild Upper Limbs Excoriation Moderate Upper Limbs Excoriation Severe Upper Limbs Oozing/weeping/crusting Absent Upper Limbs Oozing/weeping/crusting Mild Upper Limbs Oozing/weeping/crusting Moderate Upper Limbs Oozing/weeping/crusting Severe Upper Limbs Scaling Absent Upper Limbs Scaling Mild Upper Limbs Scaling Moderate Upper Limbs Scaling Severe Upper Limbs Lichenification Absent Upper Limbs Lichenification Mild Upper Limbs Lichenification Moderate Upper Limbs Lichenification Severe Trunk Erythema Absent Trunk Erythema Mild Trunk Erythema Moderate Trunk Erythema Severe Trunk Edema/induration/papulation Absent Trunk Edema/induration/papulation Mild Trunk Edema/induration/papulation Moderate Trunk Edema/induration/papulation Severe Trunk Excoriation Absent Trunk Excoriation Mild Trunk Excoriation Moderate Trunk Excoriation Severe Trunk Oozing/weeping/crusting Absent Trunk Oozing/weeping/crusting Mild Trunk Oozing/weeping/crusting Moderate Trunk Oozing/weeping/crusting Severe Trunk Scaling Absent Trunk Scaling Mild Trunk Scaling Moderate Trunk Scaling Severe Trunk Lichenification Absent Trunk Lichenification Mild Trunk Lichenification Moderate Trunk Lichenification Severe Lower Limbs Erythema Absent Lower Limbs Erythema Mild Lower Limbs Erythema Moderate Lower Limbs Erythema Severe Lower Limbs Edema/induration/papulation Absent Lower Limbs Edema/induration/papulation Mild Lower Limbs Edema/induration/papulation Moderate Lower Limbs Edema/induration/papulation Severe Lower Limbs Excoriation Absent Lower Limbs Excoriation Mild Lower Limbs Excoriation Moderate Lower Limbs Excoriation Severe Lower Limbs Oozing/weeping/crusting Absent Lower Limbs Oozing/weeping/crusting Mild Lower Limbs Oozing/weeping/crusting Moderate Lower Limbs Oozing/weeping/crusting Severe Lower Limbs Scaling Absent Lower Limbs Scaling Mild Lower Limbs Scaling Moderate Lower Limbs Scaling Severe Lower Limbs Lichenification Absent Lower Limbs Lichenification Mild Lower Limbs Lichenification Moderate Lower Limbs Lichenification Severe
    Number of subjects analysed
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    43
    Units: percentage of participants
    number (not applicable)
        Baseline [n=43]
    34.9
    39.5
    23.3
    2.3
    51.2
    37.2
    11.6
    0
    60.5
    27.9
    11.6
    0
    86
    9.3
    4.7
    0
    60.5
    39.5
    0
    0
    74.4
    25.6
    0
    0
    2.3
    41.9
    48.8
    7
    9.3
    46.5
    39.5
    4.7
    7
    46.5
    39.5
    7
    55.8
    32.6
    11.6
    0
    30.2
    55.8
    14
    0
    23.3
    55.8
    20.9
    0
    34.9
    53.5
    11.6
    0
    62.8
    30.2
    7
    0
    65.1
    20.9
    9.3
    4.7
    86
    9.3
    4.7
    0
    60.5
    39.5
    0
    0
    72.1
    25.6
    2.3
    0
    4.7
    23.3
    55.8
    16.3
    14
    30.2
    48.8
    7
    14
    27.9
    48.8
    9.3
    53.5
    34.9
    11.6
    0
    23.3
    60.5
    16.3
    0
    30.2
    48.8
    18.6
    2.3
        Day 10 [n=37]
    51.4
    43.2
    5.4
    0
    75.7
    24.3
    0
    0
    83.8
    16.2
    0
    0
    94.6
    5.4
    0
    0
    75.7
    24.3
    0
    0
    81.1
    18.9
    0
    0
    8.1
    62.2
    29.7
    0
    27
    67.6
    5.4
    0
    13.5
    64.9
    21.6
    0
    73
    24.3
    2.7
    0
    45.9
    51.4
    2.7
    0
    40.5
    51.4
    8.1
    0
    56.8
    35.1
    8.1
    0
    78.4
    21.6
    0
    0
    73
    27
    0
    0
    91.9
    8.1
    0
    0
    78.4
    21.6
    0
    0
    81.1
    18.9
    0
    0
    8.1
    56.8
    35.1
    0
    21.6
    56.8
    18.9
    2.7
    13.5
    70.3
    16.2
    0
    78.4
    21.6
    0
    0
    40.5
    51.4
    8.1
    0
    40.5
    43.2
    16.2
    0
        Week 3 [n=30]
    50
    43.3
    6.7
    0
    70
    26.7
    3.3
    0
    76.7
    20
    3.3
    0
    100
    0
    0
    0
    73.3
    26.7
    0
    0
    90
    10
    0
    0
    0
    76.7
    20
    3.3
    30
    53.3
    16.7
    0
    26.7
    53.3
    20
    0
    80
    20
    0
    0
    46.7
    50
    3.3
    0
    43.3
    56.7
    0
    0
    60
    30
    10
    0
    73.3
    20
    6.7
    0
    70
    23.3
    6.7
    0
    93.3
    6.7
    0
    0
    90
    10
    0
    0
    80.8
    20
    0
    0
    3.3
    46.7
    43.3
    6.7
    23.3
    43.3
    33.3
    0
    26.7
    46.7
    23.3
    3.3
    66.7
    26.7
    6.7
    0
    40
    53.3
    6.7
    0
    40
    53.3
    6.7
    0
        Week 3 LOCF [n=42]
    45.2
    45.2
    9.5
    0
    71.4
    26.2
    2.4
    0
    78.6
    19
    2.4
    0
    97.6
    2.4
    0
    0
    69
    31
    0
    0
    85.7
    14.3
    0
    0
    2.4
    71.4
    23.8
    2.4
    35.7
    50
    14.3
    0
    26.2
    52.4
    21.4
    0
    83.3
    14.3
    2.4
    0
    45.2
    52.4
    2.4
    0
    40.5
    52.4
    7.1
    0
    54.8
    35.7
    9.5
    0
    71.4
    23.8
    4.8
    0
    69
    26.2
    4.8
    0
    92.9
    7.1
    0
    0
    83.3
    16.7
    0
    0
    78.6
    21.4
    0
    0
    4.8
    42.9
    47.6
    4.8
    23.8
    38.1
    35.7
    2.4
    23.8
    45.2
    28.6
    2.4
    71.4
    23.8
    4.8
    0
    42.9
    50
    7.1
    0
    35.7
    50
    14.3
    0
        Week 6 [n=30]
    60
    36.7
    3.3
    0
    80
    20
    0
    0
    83.3
    16.7
    0
    0
    100
    0
    0
    0
    90
    10
    0
    0
    90
    10
    0
    0
    20
    56.7
    20
    3.3
    46.7
    36.7
    13.3
    3.3
    23.3
    53.3
    23.3
    0
    80
    20
    0
    0
    56.7
    43.3
    0
    0
    43.3
    50
    6.7
    0
    63.3
    30
    6.7
    0
    80
    16.7
    3.3
    0
    73.3
    23.3
    3.3
    0
    93.3
    6.7
    0
    0
    86.7
    13.3
    0
    0
    80
    16.7
    3.3
    0
    10
    46.7
    33.3
    10
    33.3
    40
    16.7
    10
    20
    53.3
    20
    6.7
    70
    23.3
    6.7
    0
    56.7
    33.3
    10
    0
    40
    43.3
    16.7
    0
        Week 6 LOCF [n=43]
    53.5
    37.2
    9.3
    0
    74.4
    23.3
    2.3
    0
    76.7
    20.9
    2.3
    0
    97.7
    2.3
    0
    0
    79.1
    20.9
    0
    0
    88.4
    11.6
    0
    0
    14
    60.5
    20.9
    4.7
    39.5
    46.5
    11.6
    2.3
    23.3
    51.2
    25.6
    0
    81.4
    16.3
    2.3
    0
    46.5
    51.2
    2.3
    0
    41.9
    51.2
    7
    0
    53.5
    37.2
    9.3
    0
    76.7
    16.3
    7
    0
    69.8
    23.3
    7
    0
    93
    7
    0
    0
    81.4
    18.6
    0
    0
    81.4
    16.3
    2.3
    0
    7
    44.2
    39.5
    9.3
    25.6
    39.5
    27.9
    7
    20.9
    48.8
    23.3
    7
    74.4
    20.9
    4.7
    0
    48.8
    39.5
    11.5
    0
    39.5
    41.9
    18.6
    0
    No statistical analyses for this end point

    Secondary: Patient's/Guardian's/Parent(s) Assessment of Global Response

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    End point title
    		 Patient's/Guardian's/Parent(s) Assessment of Global Response
    End point description
    The study analysis population for this endpoint consisted of the FAS. Patient’s/Guardian’s/Parent(s) Assessment of Global Response: The patient/guardian/parent(s) was instructed to answer the following questions at day 10, week 3 & week 6 (visits 3-5). “Consider your atopic dermatitis as a whole, how it looks, how it feels, how others react to it etc. Since the time you started treatment with the study substance, do you think the condition is”: Much Improved Improved Slightly Improved Same Slightly Worse Worse Much Worse
    End point type
    Secondary
    End point timeframe
    Day 10, Week 3 and Week 6.
    End point values
    		 AD Much Improved AD Improved AD Slightly Improved AD Same AD Slightly Worse AD Worse AD Much Worse
    Number of subjects analysed
    43
    43
    43
    43
    43
    43
    43
    Units: percentage of participants
    number (not applicable)
        Day 10 [n=36]
    36.1
    19.4
    27.8
    11.1
    2.8
    0
    2.8
        Week 3 [n=30]
    33.3
    23.3
    13.3
    10
    16.7
    0
    3.3
        Week 3 LOCF [n=41]
    34.1
    19.5
    17.1
    9.8
    14.6
    0
    4.9
        Week 6 [n=28]
    39.3
    28.6
    3.6
    17.9
    7.1
    3.6
    0
        Week 6 LOCF [n=42]
    33.3
    31
    4.8
    16.7
    9.5
    2.4
    2.4
    No statistical analyses for this end point

    Secondary: Change in Euroquol 5 Dimensions Questionnaire (EQ-5D) from baseline to Week 6

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    End point title
    		 Change in Euroquol 5 Dimensions Questionnaire (EQ-5D) from baseline to Week 6
    End point description
    The study analysis population for this endpoint consisted of the FAS. The EQ-5D comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each dimension comprises three levels (1=no problems, 2=some/moderate problems, 3=extreme problems). The EQ-5D VAS records the respondents-rated health status on a vertical graduated VAS ranging from 0 indicating the worst imaginable state to 100 indicating the best imaginable state of the patient’s health. EQ-5D questionnaire was used to calculate the utility of an individual patient and produces a utility value of between 0 (death) and 1 (perfect health). The EQ-5D was not completed for children less than 3 years of age.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6.
    End point values
    		 Locobase REPAIR® Twice daily
    Number of subjects analysed
    23
    Units: EQ-5D VAS and Utility Scores
    arithmetic mean (standard deviation)
        EQ-5D VAS
    7.7 ( 12.2 )
        EQ-5D Utlity Score TTO UK
    0.13 ( 0.24 )
        EQ-5D Utility Score VAS UK
    0.13 ( 0.2 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Dermatology Life Quality Index (CDLQI) ] from baseline to Week 6

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    End point title
    		 Change in Children’s Dermatology Life Quality Index (CDLQI) ] from baseline to Week 6
    End point description
    The study analysis population for this endpoint consisted of the FAS. The CDLQI consists of 10 questions and was completed by the patients themselves with help from their parent(s)/guardian where necessary. The CDLQI was calculated by summing the score of each question resulting in a total score between 0 and 30. Furthermore, six subscores were calculated. The higher the score, the more QoL is impaired. Children under 5 years of age were not asked to complete the CDLQI.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6.
    End point values
    		 Locobase REPAIR® Twice daily
    Number of subjects analysed
    43
    Units: CDLQI Scores
    arithmetic mean (standard deviation)
        CDLQI Total Score [n=16]
    -5.1 ( 6.5 )
        CDLQI Subscore Symptoms and Feelings [n=17]
    -1.6 ( 1.6 )
        CDLQI Subscore Leisure [n=17]
    -1.2 ( 2.2 )
        CDLQI Subscore School and Holiday [n=3]
    -0.7 ( 1.2 )
        CDLQI Subscore Personal Relationship [n=16]
    -0.4 ( 1.7 )
        CDLQI Subscore Sleep [n=15]
    -0.7 ( 1 )
        CDLQI Subscore Treatment [n=16]
    -0.6 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Resource Utilization Questionnaire

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    End point title
    		 Resource Utilization Questionnaire
    End point description
    The study analysis population for this endpoint consisted of the FAS. The Resource Utilization Questionnaire was used to record the patients’ visits to a general practitioner (GP) for AD, the patients’ hospital outpatient visits and the patients’ admissions due to AD during the study. Patients completed a resource utilization questionnaire at all visits.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 10, Week 3 and Week 6.
    End point values
    		 Patients with at least one visit to a GP Patients with at least one outpatient visit to a hospital
    Number of subjects analysed
    43
    43
    Units: percentage of participants
    number (not applicable)
        Up to 91 days before Baseline - ≥ Baseline [n=43]
    41.9
    9.3
        > Baseline - ≤ Day 10 [n=43]
    16.3
    4.7
        > Baseline - ≤ Week 3 [n=43]
    16.3
    4.7
        > Baseline - ≤ Week 6 [n=43]
    16.3
    4.7
        > Day 10 - ≤ Week 3 [n=30]
    3.3
    3.3
        > Week 3 - ≤ Week 6 [n=31]
    3.2
    0
    No statistical analyses for this end point

    Secondary: Safety as assessed by recording adverse events, and laboratory assessments

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    End point title
    		 Safety as assessed by recording adverse events, and laboratory assessments
    End point description
    The study analysis population for this endpoint consisted of the Safety analysis set (SAF). The SAF consisted of all enrolled patients who used Locobase REPAIR®. Treatment emergent adverse events (TEAE) were those events that commenced on the day or after the first day that study medication was dispensed, unless indicated by the investigator as before first application of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Week 6.
    End point values
    		 Application site Non-application site Overall Participants with Treatment-Emergent Adverse Events
    Number of subjects analysed
    49
    49
    49
    Units: Participants
        Total TEAEs
    8
    10
    16
        Serious Adverse Events (SAEs)
    0
    1
    1
        Deaths
    0
    0
    0
        Discontinued due to AEs
    3
    2
    4
        TEAEs Mild
    4
    5
    8
        TEAEs Moderate
    4
    4
    7
        TEAEs Severe
    0
    1
    1
        Treatment related AEs
    4
    0
    4
        Total treatment-related AEs
    8
    0
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    TEAEs were those events that commenced on the day or after the first day that study medication was dispensed, unless indicated by the investigator as before first application of study drug.
    Adverse event reporting additional description
    An adverse event was defined as any untoward medical occurrence in a patient entered into the study, which did not necessarily have a causal relationship with the treatment. The study analysis population for this endpoint consisted of the SAF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1.10
    Reporting groups
    Reporting group title
    Locobase REPAIR® Twice daily
    Reporting group description
    		 Locobase REPAIR® cream to be applied twice daily to all areas with active lesions or dry skin either present at day 1 or that emerge during the study.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events within the 5% or more frequency threshold for reporting non-serious adverse events.
    Serious adverse events
    		 Locobase REPAIR® Twice daily
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 49 (2.04%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Locobase REPAIR® Twice daily
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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